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For Companies At a Glance
- Tasks: Join our medical writing team to create clinical and regulatory documents for exciting projects.
- Company: CK Group is a leading consultancy specializing in Advanced Therapies and Rare Diseases.
- Benefits: Enjoy a competitive salary up to £70,000 and a flexible remote work environment.
- Why this job: Make an impact in healthcare while working with a dynamic team on innovative therapies.
- Qualifications: You need a B.Sc. in life sciences and experience in regulatory document preparation.
- Other info: Open to permanent, contract, or part-time roles.
The predicted salary is between 42000 - 84000 £ per year.
Job Description
CK Group are recruiting for a Senior Regulatory and Medical Writer to join a leading, dynamic and fast-growing consultancy on a permanent basis. They specialise in Advanced Therapies and Rare Diseases. This will be a fully remote role and candidates looking for permanent, contract or part-time roles will be considered.\\n\\nRESPONSIBILITIES:\\n\\n Working as part of the medical writing team, you will be supporting the regulatory affairs, clinical operations and medical affairs teams across a range of projects, and directly with clients for standalone medical writing projects.\\n\\nPreparation of clinical documents such as clinical study protocols and amendments, clinical study reports, and investigator’s brochures/investigator’s brochure updates.\\nPreparation of EU and US regulatory documents.\\nProject management.\\nManaging the document review process.\\nOrganizing the quality control (QC) review of documents and addressing QC comments.\\nEditorial support and formatting of documents authored by other team members as required.\\nPeer review of documents authored by other colleagues.\\nProviding guidance and training to less experienced medical writers and members of the wider team.\\nQUALIFICATIONS:\\n\\nAs Senior Regulatory and Medical Writer you will require:\\n\\nProven experience gained in a consultancy environment, with a minimum of a B.Sc.
in a life sciences subject (a higher degree would be a distinct advantage).\\nExcellent written and verbal communication skills, including the ability to articulate ideas clearly, engage with diverse audiences, and produce error-free written content.\\nProficient in Microsoft Office with excellent skills in Word.\\nExperience in preparing clinical documents.\\nSignificant experience with the preparation of EU and US regulatory documents would be a distinct advantage.\\nProject management skills, including the creation and maintenance of project timelines and liaison with clients.\\nBENEFITS:\\n\\nSalary of up to £70,000 plus benefits package.\\n\\nAPPLY:\\n\\n Please quote job reference (Apply online only) in all correspondence.\\n\\nIf this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news
Senior Regulatory and Medical Writer employer: CK Group- Science, Clinical and Technical
Contact Detail:
CK Group- Science, Clinical and Technical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory and Medical Writer
✨Tip Number 1
Familiarize yourself with the latest regulations and guidelines for clinical documents in both the EU and US. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory and medical writing space. Engaging with others in the industry can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Showcase your project management skills by discussing specific projects you've managed in the past. Highlight how you maintained timelines and communicated effectively with clients, as this is crucial for the role.
✨Tip Number 4
Prepare to discuss your experience with quality control processes during interviews. Being able to articulate how you've handled document reviews and addressed QC comments will set you apart from other candidates.
We think you need these skills to ace Senior Regulatory and Medical Writer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory and Medical Writer position. Understand the responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory writing, particularly in preparing clinical documents and EU/US regulatory submissions. Use specific examples to demonstrate your expertise.
Showcase Communication Skills: Since excellent written and verbal communication skills are crucial for this role, provide examples of how you've effectively communicated complex ideas in your previous roles. This could be through reports, presentations, or client interactions.
Tailor Your Application: Customize your cover letter to reflect your understanding of the consultancy environment and your passion for advanced therapies and rare diseases. Mention why you are interested in this specific role and how you can contribute to the team.
How to prepare for a job interview at CK Group- Science, Clinical and Technical
✨Showcase Your Writing Skills
As a Senior Regulatory and Medical Writer, your writing skills are crucial. Prepare samples of your previous work, especially clinical documents, to demonstrate your ability to produce clear and error-free content.
✨Understand Regulatory Requirements
Familiarize yourself with EU and US regulatory documents. Be ready to discuss your experience in preparing these documents and how you ensure compliance with regulations during the writing process.
✨Highlight Project Management Experience
Since project management is a key responsibility, be prepared to share examples of how you've managed timelines, liaised with clients, and organized document reviews in past roles.
✨Engage with the Team Dynamics
This role involves collaboration with various teams. Be ready to discuss how you’ve worked with medical affairs, clinical operations, and other stakeholders, and how you can contribute to a positive team environment.
